Schuessler Combination P Tissue Salts 125 Tablets

279 Princeton-Hightstown RoadEast Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 02/2026 This Patient Information has been approved by the U.S.

• For best results, take sildenafil on an empty stomach.
• Eating fatty foods may delay its onset.
• The medication should be taken approximately 30 minutes before activity.
• Do not double dose to compensate for missed doses.
• Keep regular medical appointments during treatment.
• Report any worsening of symptoms to your doctor.
• Never use sildenafil if experiencing chest pain without medical guidance.
• Always follow the prescribed health regimen.

Food and Drug Administration. Instructions for Use Sildenafil (sil den' a fil) Read this Instructions for Use before you start taking sildenafil oral suspension or giving sildenafil oral suspension to your child and each time you get a refill. This information does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment.

Step	Description	Notes
Consult a healthcare provider	Discuss suitability and health conditions	Important before use
Dose administration	Take with a glass of water, 30-60 min before activity	Avoid heavy or fatty meals
Frequency	Do not exceed once per day	Follow prescribed instructions
Food interactions	Fatty meals may delay absorption	Better taken on an empty stomach or light meal

Ask your healthcare provider or pharmacist to show you how to measure and take or give your child’s prescribed dose of sildenafil for oral suspension. Your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you.

• Sildenafil tablets 125 mg can be part of a broader ED treatment plan.
• Psychological counseling may enhance effectiveness.
• Combining therapies can improve outcomes.
• Lifestyle modifications include weight management and exercise.
• Quitting smoking can improve erectile health.
• Vasodilator drugs should be avoided when using sildenafil.
• Maintain a balanced diet alongside medication.
• Support groups can offer additional assistance.

Do not take or give sildenafil for oral suspension and contact your pharmacist if the medicine in the bottle is still a powder.

Highlights of Prescribing Information

Count of non-elective hospital stays for worsening PAH as sildenafil products over the counter the first event of clinical worsening. d. Count of deaths as the first event of clinical worsening. e. Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.

Dosage for pulmonary arterial hypertension (PAH)

Sildenafil for Oral Suspension, 10 mg/mL is supplied in amber pet bottles. Each bottle contains white to off-white granular powder containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. Recommended Storage for Sildenafil for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. Always use the oral dosing syringe that comes with sildenafil for oral suspension.

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If your carton does not come with an oral dosing syringe, contact your pharmacist.

5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil group compared with 4 meters for the placebo group giving an adjusted treatment difference of 26 meters (95% CI: 10.8, 41.2) (p = 0.0009). Patients on sildenafil achieved a statistically significant reduction in mPAP compared to those on placebo. A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favor of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003). Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than sildenafil-treated patients and that sildenafil-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074). Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1 Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil compared to placebo.

What should I tell my healthcare provider before taking sildenafil?

More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. Study A1481243 (NCT00323297) - Sildenafil Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months. Patients (38% male and 62% female) had body weight ≥ 8 kg and had idiopathic pulmonary arterial hypertension (33%), or PAH associated with congenital heart disease (systemic-to-pulmonary shunt 37%, surgical repair 30%). In this trial, 27% of patients were < 7 years old. The primary objective of the study was to assess the effect of sildenafil on percent change from baseline in PVO2, normalized to body weight, from baseline to week 16 as measured by the Cardiopulmonary Exercise Test (CPET) (patients who were developmentally able to perform the test, n = 115). Do not take or give sildenafil for oral suspension if the bottle adaptor is not in the bottle.

• Sildenafil tablets 125 mg are manufactured by various brands.
• Always verify the authenticity of medication sources.
• Use only FDA-approved or certified pharmacies.
• Cost can vary based on brand and location.
• Generic versions are typically more affordable.
• Beware of counterfeit sildenafil products.
• Read customer reviews before purchasing online.
• Consult your doctor about the best brand for you.

If the bottle adaptor is not in the bottle, contact your pharmacist.

Full Prescribing Information

A total of 45% of patients were evaluable for CPET, which comprised those children ≥ 7 years old and developmentally able to perform the test. Children < 7 years were evaluable only for the secondary endpoints. Percentage Change from Baseline in VO2Peak: Mean (95% Confidence Intervals) The estimated difference between the combined sildenafil doses and placebo was 8% (95% CI: - 0.2 to 16). The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p = 0.056). The estimated difference between the sildenafil medium dose group and placebo was 11 ± 5% (95% CI: 2 to 21).

2.3 Reconstitution of the Powder for Oral Suspension

Dose related improvements were observed with PVRI and mPAP. Patients who had been in the placebo group in the shortterm study were randomly reassigned to sildenafil treatment; patients weighing ≤ 20 kg entered the medium or high dose groups (1:2), while patients weighing > 20 kg entered the low, medium, or high dose groups (1:1:1). Similarly, 191 of 229 patients (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94%, 93%, and 85% in the low, medium, and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94% and 93% for patients in the medium and high dose groups, respectively [see Use in Specific Populations (8.4) and Adverse Reactions (6.1)]. Study A1481324 (NCT02060487) - Study to Assess the Effects of Sildenafil on Mortality in Adults with PAH A study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH was conducted following the observation of a higher risk of mortality in pediatric patients taking a high dose of sildenafil TID, based on body weight, compared to those taking a lower dose of sildenafil in the long-term extension of the pediatric clinical trial. At the time of a planned interim analysis (50% deaths) it was identified that the primary efficacy objective of this protocol was met and therefore the study was stopped. Sildenafil for oral suspension should not be mixed with any other medicine or flavoring.

3. Dosage Forms and Strengths

Primary comparison of the 80 mg TID group to the 5 mg TID group yielded the HR (99.7% CI) = 0.51 (0.22, 1.21); i.e., non-inferiority was established. Hazard Ratios for Overall Survival, Assessed in the Proportional Hazards Model – Intent To Treat Population On treatment deaths: Any death within 7 days of last dose was regarded as “On treatment”, thus might include deaths occurred after discontinuation from study treatment. Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH. Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80- mg TID dose groups, respectively. Sildenafil 80 mg was also superior to 5 mg for time to first event of clinical worsening with HR (99.7% CI) = 0.44 (0.22, 0.89).

Warnings for people with certain health conditions

Hazard Ratios for Time to First Event of Clinical Worsening – Intent To Treat Population Note: Sildenafil 5 mg is not an approved dosage. Abbreviations: 6MWD = 6-minute walk distance; CI = confidence interval; PAH = pulmonary arterial hypertension. Clinical worsening events were defined as reduction from baseline in the 6MWD test by at least 15% and worsening functional class from baseline, both confirmed by a second test/evaluation within 2 weeks. Count of cases of disease progression as the first event of clinical worsening. c. Supplies you will need to take or give a dose of sildenafil for oral suspension (See Figure A): 1 bottle of sildenafil for oral suspension with pre-inserted bottle adaptor 1 oral dosing syringe (provided in the carton) Shake the bottle of sildenafil oral suspension for 10 seconds before each use.

• Sildenafil tablets 125 mg are often prescribed for pulmonary hypertension.
• The dosage can vary depending on the condition.
• It’s important to maintain open communication with your doctor.
• Alcohol consumption can impair sildenafil’s effectiveness.
• Avoid driving if you experience dizziness or vision problems.
• Use sildenafil exactly as prescribed to avoid complications.
• Do not share medication with others.
• Regular medical check-ups are recommended during use.

Open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). Fully push down (depress) the plunger of the oral dosing syringe. Then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface.

Country	Legal Status	Prescription Required	Notes
USA	Prescription required	Yes	Approved for ED, PH
UK	Prescription required	Yes	Prescription necessary
India	Over-the-counter in some states	Varies	Varies by region
Canada	Prescription required	Yes	Approved for ED and PH

Turn the bottle upside down while holding the oral dosing syringe in place.

8.4 Pediatric Use

Advise patients taking sildenafil for oral suspension not to take VIAGRA or other PDE-5 inhibitors. Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil for oral suspension. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil for oral suspension. The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. Distributed by: Aurobindo Pharma USA, Inc. Slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the mL marking on the syringe for your or your child’s prescribed dose. If your or your child's dose of sildenafil for oral suspension is more than 2 mL (20 mg), you will need to divide the dose.

Region	Average Cost per Pack	Pack Quantity	Notes
USA	$30 - $50	30 tablets	Generic versions available
UK	£15 - £25	30 tablets	Prescribed or OTC in some areas
India	₹150 - ₹300	10-30 tablets	Widely available, generic options
Australia	AUD 40 - AUD 70	30 tablets	Prescription required

Follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose. If you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil for oral suspension flows back into the bottle and repeat Step 4. Turn the bottle back upright with the oral dosing syringe still in place.

8.7 Hepatic Impairment

Recommended Storage for Reconstituted Oral Suspension: Store below 30°C (86°F) or in refrigerator at 2° to 8°C (36° to 46°F). The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients of contraindication of sildenafil for oral suspension with regular and/or intermittent use of organic nitrates.